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Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molly A. Wanner, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01149876
First received: April 30, 2010
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to determine whether a topical Nu Skin product with or without a galvanic spa device improves brown spots on the face. The Nu Skin product will be compared to an over the counter moisturizer and tretinoin cream.


Condition Intervention Phase
Hyperpigmentation
Other: Nu Skin Product
Other: Cosmetic instrument
Drug: Tretinoin cream 0.05
Other: CeraVe moisturizer
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Single Blind, Placebo Controlled Trial to Evaluate Effects of a Study Medication, a Nu Skin Lightening Product With and Without Iontophoresis vs Tretinoin Cream vs Vehicle Control for Facial Hyperpigmentation

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Hyperpigmentation of the Face [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]

    Primary outcome measure will be change in hyperpigmentation of baseline compared to week 16.

    Hyperpigmentation will be measured clinically using a 0-6 scale where 0 is no hyperpigmentation and 6 is very severe hyperpigmentation.



Secondary Outcome Measures:
  • Change in Rhytides [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]

    Secondary outcome measures will be change in rhytides of baseline compared to week 16.

    Rhytides will be assessed clinically using a 0-6 scale where 0 is no lines and 6 is very deep lines.



Enrollment: 80
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nu Skin Product Other: Nu Skin Product
Thin layer of Nu Skin product applied to face.
Experimental: Nu Skin product with galvanic spa system Other: Nu Skin Product
Thin layer of Nu Skin product applied to face.
Other: Cosmetic instrument
Cosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes.
Active Comparator: Tretinoin cream 0.05 Drug: Tretinoin cream 0.05
Thin layer of tretinoin applied to face.
Placebo Comparator: over the counter moisturizer Other: CeraVe moisturizer
Thin layer of CeraVe applied to face.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to understand and sign informed consent.
  • Able to complete study and comply with study procedures.
  • Caucasian female ages 25-55.
  • Presence of photodamage and lentigines of II-III on the Glogau Photoaging
  • Must be willing to avoid laser and light treatments, treatments with filler, chemical peels, microdermabrasion, Botox or any other cosmetic treatment to the face during the duration of the study.
  • Must be willing to avoid changing topical moisturizers and cosmetics during the study.
  • Able to stop any alpha or beta hydroxy acids, topical retinol or retinoid derivatives, topical antioxidants, or any topical product that may interfere with the study 2 weeks prior to the study.

Exclusion Criteria:

  • Cosmetic treatment of face, such as laser or light treatment, filler, Botox, microdermabrasion, or chemical peels 6 months prior to study or during study.
  • Current smoker.
  • Pregnant, nursing, or planning to become pregnant during study.
  • Currently taking drugs including oral retinoids or any other medication with a known clinically significant drug interaction with topical tretinoin.
  • Known hypersensitivity to retinoids. History of severe retinoid dermatitis.
  • History of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study.
  • Concurrent participation in another clinical study or participation 30 days prior to enrollment that includes exposure to an investigational drug that would interfere with this study.
  • Any disease or condition which would interfere with study participation or unduly increase risk.
  • Presence of an electrically sensitive support system such as a pacemaker.
  • Known history of epilepsy.
  • Presence of metal implants or metal braces on teeth.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149876

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Molly Wanner, MD MGH
  More Information

No publications provided

Responsible Party: Molly A. Wanner, MD, Assistant Physician, Dermatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01149876     History of Changes
Other Study ID Numbers: 2009-P-002803
Study First Received: April 30, 2010
Results First Received: January 10, 2014
Last Updated: October 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Tretinoin
Antineoplastic Agents
Dermatologic Agents
Keratolytic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014